Skip to main content
OpenTrials
Completed

NCT Number: NCT02424656

Alterations in the Brain's Connectome After Severe Traumatic Brain Injury

This study explores the changes in whole-brain connectivity that occur during recovery from severe Traumatic Brain Injury and how these changes are related to the recovery of consciousness. Multimodal neuroimaging techniques will be used in a longitudinal fashion while patients are undergoing neurorehabilitation and after one-year of the TBI episode.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Consciousness Disorders Craniocerebral Trauma Disorders of Consciousness Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Danish Research Centre for Magnetic Resonance

Copenhagen, 2650, Denmark

About this study

Severe Traumatic Brain Injury (TBI) can result in a long-lasting altered state of consciousness. At present, the underlying neurological determinants of recovery in patients with disorders of consciousness (DOC) after a severe TBI are not well understood, and individual prognosis is very limited. Moreover, the rate of misdiagnosis between different states of altered consciousness by standard clinical scales is high, which further impacts on the clinical prognosis. In this project, multimodal neuroimaging measures will be applied and whole-brain data will be obtained from patients recovering from severe TBI in a longitudinal fashion. Patients will be examined at four time points during the sub-acute stage: immediately after admission to the neurorehabilitation unit, after ten weeks of admission, at discharge, and after one year of the TBI episode. Brain connectivity will be assessed with functional Magnetic Resonance Imaging (fMRI) combined with electroencephalography (EEG), structural MRI, diffusion MRI, high-density EEG (hdEEG) alone, and hdEEG combined with Transcranial Magnetic Stimulation (EEG-TMS), and [18F]-fluorodeoxyglucose positron emission tomography (FDG-PET).

The overall aim of the study is to find reliable biomarkers for the recovery of consciousness based on changes in cortico-cortical and cortico-subcortical brain connectivity. In order to explore this, patients that suffered a severe TBI as well a matched healthy participants group will be included in the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Patient's inclusion criteria:

  • closed-head injury

Patient's exclusion criteria:

  • high level of consciousness after coma
  • ventricular shunt for hydrocephalus
  • large intracerebral hemorrhages or infarctions
  • structural lesions in the brain stem
  • locked-in syndrome due to motor pathway lesions
  • contraindications for MR
  • contraindications for TMS

Healthy participant's inclusion criteria:

  • no prior history of neurological disorders and / or head injury

Healthy participant's exclusion criteria:

  • contraindications for MR
  • contraindications for TMS

Treatment and study plan

MRI

Procedure

EEG-functional MRI, structural MRI, diffusion MRI

Other names: Magnetic Resonance Imaging

TMS-EEG

Procedure

Single pulse TMS combined with EEG, resting-state EEG, noise masking (auditory stimulation), electrical stimulation

Other names: Transcranial Magnetic Stimulation-Electroencephalogram

FDG-PET

Procedure

Other names: [18F]-fluorodeoxyglucose positron emission tomography

Clinical Scales

Other

Evaluation of DOC: Coma recovery scale-Revised (CRS-R) and Rancho Los Amigos Scale (RLAS). Evaluation of function: Functional Independent Measure (FIMTM), and Early Functional Assessment (EFA).

Primary outcomes

  1. Changes in whole brain connectivity as a measure of recovery of consciousness

    Time frame: up to 32 months

Sponsors and collaborators

Lead sponsor

Danish Research Centre for Magnetic Resonance

Other

Collaborators

  • Danish Council for Independent Research
  • Glostrup University Hospital, Copenhagen
  • Lundbeck Foundation
  • Region Capital Denmark
  • University of Kiel
  • University of Milan

Registry information

Official study title

Alterations in the Brain's Connectome in Severe Traumatic Brain Injury

Acronym: ABCinTBI

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2015
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.